In clinical studies or trials, effectiveness of a medicament can be proved by treating a group of patients with a medicament while treating a comparative group of patients with an inert or inactive substance, like a physiological saline solution, substantially acting as a placebo.
However, depending on the type of administration of the medicament and depending on generic properties of the medicament, it may be inadmissible to administer the inert substance to the patient. If for instance a parenteral medicament features a particular colour it would be inadmissible to dye a comparative inert substance accordingly. In such cases, administration of the inert substance to the patient has to be pretended or simulated. However, neither patient nor medical staff should become aware of the pretended administration of the medicament.
Document U.S. Pat. No. 6,544,250 B1 for instance describes a device for blinding the administration of non-solid pharmaceutical presentations in clinical trials without using the so-called double-blind technique. This device is particularly designed for intrapulmonary administration of a medicament. The device comprises a blinding bag having at least two attachments. One of said attachments is intended for connection to a dispenser for the pharmaceutical presentation and the other attachment is intended for connection to an applicator.
The inside of said bag has means for holding back the pharmaceutical presentation, wherein the attachment intended for connection to the applicator has a closure inside the container. Another embodiment of said blinding bag comprises two similar attachments, wherein the attachments have a continuous connection in the inside of the container, thus ensuring that the pharmaceutical presentation is transported through the container.
However, such blinding device is not suitable for clinical trials, in which the medicament has to be administered to the patient by way of injection. Also when holding back the pharmaceutical presentation, the blinding bag may gain weight which may be perceptible by either medical staff or by the patient, thereby increasing a risk of unblinding.
It is therefore an object of the present invention to provide a blinding device and a blinding kit being universally applicable to different kinds of administration of medicaments, pharmaceutical substances as well as to inert or placebo substances. It is a further aim to increase patient safety and to improve the blinding of pharmaceutical or inert substances and to reduce a risk of unblinding, both to the patient as well as to medical staff.